A 3-month, phase 2, single-blind, randomised, no-treatment controlled study assessing efficacy and safety of Renaparin® for improvement of kidney graft function in deceased-donor transplant recipients, with an additional 9-month follow-up.
This research study is looking into a new medicine called Renaparin®. It's for people who have received a kidney transplant from a deceased donor because their own kidneys had stopped working properly. The main goal is to find out if Renaparin® helps the new kidney work better. Researchers will measure how well the kidney is working after three months. Some people will receive Renaparin®, and others will not, allowing doctors to compare the results. The study will also keep an eye on how safe the medicine is. This is a "Phase 2" study, meaning it's an early stage of testing to see if the medicine is effective and what dose might be best, with a total follow-up lasting a year.
At a glance
What is this study about?
This study is designed for people who have received a new kidney from a deceased donor. When someone has end-stage kidney disease, their kidneys can no longer clean their blood properly, and a transplant is often the best treatment. After a kidney transplant, it's very important that the new kidney starts working well as quickly as possible and continues to do so for many years. Sometimes, the new kidney might take a little while to kick in, or it might not work as well as hoped.
The researchers want to see if a new medicine, called Renaparin®, can help the donated kidney work better from the start. They will be looking closely at how well the kidney is functioning three months after the transplant using a common measurement. They will also look at safety and other details of how the new kidney performs over the first year. This is an important step in developing new treatments to help transplant recipients.
Because this is a "Phase 2" study, it means the medicine has been tested for safety in a small number of people already and is now being looked at more closely to see if it works and what kind of effect it has. Participants will be carefully monitored throughout the study to make sure everything is safe and to track their progress.
Key takeaways
- This study is for adults receiving a kidney transplant from a deceased donor.
- It aims to see if a new medicine, Renaparin®, improves how well the new kidney works.
- The main focus is on kidney function three months after transplant.
- Participation involves taking the study medicine for 3 months and follow-up checks for a full year.
- You might receive the new medicine or a comparison treatment.
- All participants will be closely monitored for safety and kidney health.
Who may be eligible?
To be able to join this study, you must be at least 18 years old. Both men and women can take part.
You would be considered for this study if you are undergoing a kidney transplant using a kidney from a deceased donor. The study is for people whose own kidneys have stopped working properly, known as end-stage renal disease, or who have significant kidney problems.
It's important that you discuss your full medical history and current health with the study doctors. They will check all your details carefully to make sure this study is right for you and that you meet all the specific requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you having a kidney transplant from a deceased donor?
- Do you have end-stage kidney disease or significant kidney problems?
- Are you able to attend regular follow-up appointments for a year?
What does participation involve?
If you decide to take part in this study, you will be given the study medicine, Renaparin®, or a treatment that doesn't contain the active medicine (this is decided by chance, like flipping a coin). You won't know which one you're getting, and neither will your doctor, to ensure fair results. The study medicine will be given for three months after your kidney transplant.
Throughout the study, you will have regular visits to the hospital or clinic. These visits will involve blood tests to check your kidney function and other health markers, and doctors will closely monitor your overall health and any side effects. These checks will happen often in the first few days and weeks after your transplant, and then at specific times later on, up to a year after your transplant. The initial treatment period is 3 months, with an additional 9 months of follow-up for a total of 12 months.
Potential risks and benefits
Locations (2)
- —UnverifiedAustria
- —UnverifiedGermany
Common questions
What is Renaparin®?
Renaparin® is a new medicine being tested to see if it can help improve how well a new kidney works after a transplant.
Why is this study being done?
The study aims to find out if Renaparin® can help donated kidneys function better in people who have had a transplant.
How long will the study last for me?
You will take the study medicine for three months, and your health will be checked for a total of 12 months after your transplant.
Will I know if I'm getting the study medicine or not?
No, neither you nor your doctors will know if you are receiving Renaparin® or the comparison treatment. This helps make the study results reliable.
What is a 'deceased-donor transplant'?
This refers to a kidney transplant where the donated kidney comes from someone who has recently passed away.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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